The problem we're solving
Small and mid-size IND sponsors are caught between two bad options: sprawling enterprise safety databases built for large MAHs, or ad-hoc spreadsheet and email processes that don't scale and can't pass an FDA inspection.
AE Connect is the intake layer that sits in between, purpose-built for teams running one to ten studies, with AI-assisted triage, a validated case workflow, and E2B(R3)-compliant output. Right-sized for where you are, ready for where you're going.
Why we built it
QORO Intelligence's team brings deep experience across pharmacovigilance, clinical operations, and quality systems at oncology, hematology, and neurodegenerative disease biotech programs. Every engagement involved the same manual, error-prone AE intake process.
We built AE Connect to solve the problem the industry has lived with for too long.
The team
QORO Intelligence is a small, focused team. We work closely with every customer.
Mark Choe
20 years of clinical operations leadership across biotech and pharmaceutical organizations, with deep expertise in clinical trial management, TMF, regulatory submissions, and global study execution. Throughout his career on the clinical side, Mark has seen the adverse event intake problem from the other end of the workflow: events missing critical information, reports arriving incomplete, and in some cases events never reported at all. He leads QORO Intelligence operations, product strategy, and commercial execution with a focus on building software that solves problems both clinical and PV teams actually face.
Jay Blatnik
Leads engineering and platform architecture at QORO Intelligence, owning the AE Connect codebase from initial build through production deployment. Full-stack expertise across the platform's React/TypeScript frontend, Fastify/Node.js backend, Prisma ORM, and PostgreSQL data layer, along with the AWS infrastructure (EC2, RDS, Nginx) hosting the platform. Jay also led the technical workstream for AE Connect's GAMP 5 Cat 5 validation documentation, building the engineering practices required for a GxP-compliant pharmacovigilance system from the ground up.
Raman Gill
Leads business development, partner relationships, and operational infrastructure at QORO Intelligence. Focused on bringing AE Connect to small and mid-size biotech programs across North America.
Board & Advisors
Senior industry leaders providing strategic guidance on pharmacovigilance, quality systems, and clinical development.
Quality Expert
Senior quality systems and pharmacovigilance leader with 15+ years of experience across oncology, hematology, and neurodegenerative disease programs. Advises QORO Intelligence on quality systems architecture, GAMP 5 validation strategy, and pharmacovigilance compliance.
PV Expert
Seasoned pharmacovigilance leader with 30 years of drug safety experience across top-tier biotech and pharmaceutical organizations, including Vice President and other senior leadership roles. Expertise spans ICSR processing, signal detection, aggregate safety reporting, PV vendor selection and oversight, and building scalable drug safety operations at small to mid-size biotech. Advises QORO Intelligence on PV operations workflow, customer fit for emerging biotech programs, and the operational realities of small biotech drug safety functions.
Delaware corporation. California team.
QORO Intelligence Inc. is incorporated in Delaware and operates out of the San Francisco Bay Area. Our engineering, product, and customer teams are all based in California.
We build in the open with our customers. Beta participants work directly with our CEO and product team, not a support queue.
What's next
AE Connect is in active beta through June 30, 2026. We're working with a small cohort of IND sponsors to validate the platform against real production workflows before full commercial launch in Q3 2026.
If you're running an IND-stage program and want to shape what we build, the beta program is open. Apply here.